title: [Hazard, risk and harm in clinical trials].
abstract: Investigators and other stakeholders involved in clinical trials are not aware about all possible harms, hazards and risks related to this activity. Different categories of harms may occur during clinical trials like: physical (injury, illness, pain, suffering, or discomfort), psychological, social, economic, legal, dignitary and relational. Clinical trial participants are not the only one stakeholder exposed to different types of hazards. Among others the most important are: investigators, sponsors, centers (where clinical trials are conducted), contract research organizations and bioethics committees. Regardless of multiple hazards, substantial harms are discovered relatively rare. This situation could be explained by a small number of high risk potential clinical trials and low social awareness about different types of possible harms. Proper education should ameliorate our knowledge about hazards, risks and harms in clinical trials.
authors.forename: Marek
authors.initials: M
authors.lastname: Czarkowski
mesh_terms: D002986:Clinical Trials as Topic / Q000009:adverse effects* / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D007722:Health Knowledge, Attitudes, Practice; D006805:Human Experimentation; D006801:Humans; D010353:Patient Education as Topic; D012107:Research Design; D035842:Research Subjects / Q000331:legislation & jurisprudence; D018570:Risk Assessment